Nasdaq: FOMX May 2017Differentiated Foam Technology with Multiple Platforms •Patented1 - United...
Transcript of Nasdaq: FOMX May 2017Differentiated Foam Technology with Multiple Platforms •Patented1 - United...
Nasdaq: FOMX
May 2017
Disclaimer
To the extent that statements contained in this presentation are not descriptions of historical facts regarding Foamix, they are forward-looking statements reflecting management’s current beliefs and expectations. Forward-looking statements are subject to known andunknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different from those anticipated by such statements. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “intends,” or “continue,” or the negative of these terms or other comparable terminology. Forward-looking statements contained in this presentation include, but are not limited to, (i) statements regarding the timing of anticipated clinical trials for our product candidates; (ii) the timing of receipt of clinical data for our product candidates; (iii) our expectations regarding the potential safety, efficacy, or clinical utility of our product candidates; (iv) the size of patient populations targeted by our product candidates and market adoption of our product candidates by physicians and patients; (v) the timing or likelihood of regulatory filings and approvals; and (vi) our revenues under our agreements with our licensees, including Bayer Healthcare and other companies.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, various factors may cause differences between our expectations and actual results, including, but not limited to, unexpected safety or efficacy data, unexpected side effects observed during preclinical studies or in clinical trials, lower than expected enrollment rates in clinical trials, changes in expected or existing competition, changes in the regulatory environment for our product candidates and our need for future capital, the inability to protect our intellectual property, and the risk that we become a party to unexpected litigation or other disputes. You should read the documents filed by Foamix with the SEC, including our prospectuses, the Risk Factors set forth therein and the documents filed as exhibits to our registration statements, of which the prospectuses are a part, completely and with the understanding that our actual future results may be materially different from what we expect. You may obtain those documents byvisiting EDGAR on the SEC website at www.sec.gov. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of the foam technology or product candidates of Foamix.
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Foamix Value Proposition
3
• Late-stage Products with Potential to Differentiate vs.Market Leaders
• Global, Unencumbered Rights to Lead Programs
• Innovative Platform Allows for Consistent, Organic Innovation
• Extensive IP portfolio
• Strong Cash Position + Recurring Revenue = Runway into 2019
• Experienced Commercial / R&D Teams in Dermatology
Clinical-Stage Lead Products
4
Product Candidate Phase 2 Phase 3 Target Milestone
Minocycline Foam
FMX101
for Moderate-Severe Acne
• Study 04 / 05 TLR announced
• Long-term safety study complete end 2017
• Initiate 3rd Phase 3 mid-2017
• NDA filing – H2 2018
FMX103
for Moderate-Severe Rosacea
• Phase 2 completed
• Phase 3 initiation mid-2017
FMX102
for Impetigo
• Pre IND meeting completed
• Photo-safety Study – H2 2016
Doxycycline Foam
FDX104
for Chemotherapy- Induced Rash• Phase 2 completed
Strong Financial Position
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• Net proceeds: US $42.3 million
• Price per share: US $6.00
IPO – September 2014
• Net proceeds: US $64.2 million
• Price per share: US $9.30
Follow-on offering, April 2015
• Cash, cash equivalents and investments: US $119 million
• Net cash used in operating activities Q1, 2017 US $12.1 million
• Existing cash provides sufficient financial runway to finance our clinical and business operations, into 2019
Cash position as of March 31, 2017
• Net proceeds: US $54.1 million
• Price per share: US $9.50
Follow-on offering, September 2016
Experienced Management Team
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Name Track record Location
Dov Tamarkin, PhD
CEO & Director
• Led multiple product developments in dermatology
• Led R&D operations in Israel, EU and USIsrael
Meir Eini
CIO• Founder of multiple healthcare ventures Israel
David Domzalski
President, US
• Head of Commercial Operations at Warner Chilcott & LEO
• Led commercial launch of Doryx® and Taclonex®US
Ilan Hadar
CFO
• Held finance roles at Israeli subsidiaries of Pfizer, HP
and BAE SystemsIsrael
Yohan Hazot
CTO• Led multiple product developments in dermatology Israel
Mitchell Shirvan, PhD
SVP, R&D
• Head of R&D, CNS division at Teva
• CEO of MacroCureIsrael
Russell Elliott, DPhil
VP, Drug Development
• VP, Product Development at Stiefel, a GSK company
• Led product development at Procter & GambleUS
Alvin Howard
VP, Regulatory Affairs
• SVP Regulatory Affairs at Warner Chilcott
• Led approvals of 14 NDA and sNDAsUS
Herman Ellman, MD
VP, Clinical Affairs
• SVP Clinical Development & Medical Affairs at Warner
ChilcottUS
Iain Stuart, PhD
VP, Clinical Development• VP Medical Affairs at LEO US
Clilco Flexiprobe
Technology
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Differentiated Foam Technology with Multiple Platforms
• Patented1 - United States: 50 US patents granted
- Worldwide: 149 Patents granted
• Capability to formulate multiple drugs
• Suitable for a variety of target sites
• Dermal alternative to oral delivery
81. As of October 30, 2016
Cream Foams (Emulsion or Emollient)
Ointment Foams (Petrolatum-based)
Waterless Hydrophilic Foams (Enhanced penetration)
Oil Foams Hydroethanolic Foams
Saccharide Foams (For wounds and burns)
Potent Solvent Foams(High solubility and delivery)
Suspension Foams (Concentrated suspensions)
Nano-Emulsion Foams (Enhanced penetration)
Lead Clinical Products
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FMX101 (Moderate-to-Severe Acne)
FMX103 (Moderate-to-Severe Rosacea)
FMX101Topical Minocycline Foam 4%For Moderate-to-Severe Acne
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Acne – the US Market • ~50 million people of all ages and races have acne in the US1
◦ Moderate-to-severe acne affects ~10 million people in the US
• >14 million physician visits per year for treatment of acne2
Classification by severity / current therapies
1. (1) AAD. Acne Stats and Facts. www.aad.org/media-resources/stats-and-facts/conditions. Accessed March 30, 2016. (2) GlobalData, EpiCast. Acne Vulgaris Epidemiology Forecast to 2022;33-34.2. Mancini AJ. Adv Stud Med. 2008;8:100-105.3. Symphony Health Services PHAST: 2016 Branded Only (accessed 1.18.17), Select Market >75% rosacea weighting removed 11
Current Branded Market (United States)3
US Dollars TRxs
Oral antibiotics $1.1 billion 1.2 mm
Topical drugs $2 billion 4.3 mm
Total $3.1 billion 5.5 mmMild AcneLess than 30 lesions
<15 Inflammatory lesions
Moderate Acne <50 Inflammatory lesions
Severe Acne
>50 Inflammatory lesions
Isotretinoin
Topicalcombinations
Topical
Oral antibiotics
Acne – the US Market (2016)Large Market Potential Despite Lack of Innovation
Source: Symphony Health Services PHAST (accessed 1.18.17). (1) market shares of the oral branded prescription acne drug market and the topical branded prescription acne drug market according to the total number of prescriptions.
Top Oral Brands US Dollars TRxs
1 SOLODYNMinocycline, Valeant
$596,079,817 565,040
2 ACTICLATEDoxycycline, Almirall
$321,951,635 388,084
3 DORYXDoxycycline, Mayne
$160,887,307 180,863
Top Topical Brands US Dollars TRxs
1 EPIDUO FRANCHISEAdapalene+BPO, Galderma
$494,186,838 1,179,329
2 ACZONE FRANCHISEDapsone, Allergan
$455,752,396 946,637
3ONEXTON/ACANYA
Clindamycin+BPO, Valeant$225,357,468 503,547
4 RETIN-A FRANCHISETretinoin, Valeant
$210,905,896 273,051
5 ZIANAClindamycin+tretinoin, Valeant
$101,534,314 150,964
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Top brands oral and topical formulations (LTM December, 2016)
Solodyn, 54%Acticlate, 29%
Doryx, 15%
All Other Oral ABs, 2%
TRx Market Share Oral Brands(1)
Epiduo Franchise
25%
Aczone Franchise23%
Onexton/Acanya11%
Retin-A Franchise10%
Ziana5% All Other
Topicals26%
TRx Market Share Topical Brands(1)
Phase 3: Design of Each Pivotal Study (x2)Studies FX2014-04 & FX2014-05
• Self-apply, once daily, in the evening, for 12 weeks
• Inclusion criteria◦ At least 20 inflammatory and 25 non-inflammatory lesions◦ IGA 6 point scale – Moderate or Severe (Grade 3 or 4)
• Co-Primary Efficacy Endpoints◦ Mean change from baseline in inflammatory lesion count◦ Proportion of subjects with IGA scores of “Clear” or “Almost Clear”, with improvement of at least
2 grades from baseline
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12-week, randomized, double-blind, vehicle controlled, in subjects with moderate-to-severe acne; followed by 9 month open label safety extension
Week 12(End of treatment)
12 MonthsWeek 3 Week 6 Week 9
Double-blinded PhaseRandomized (2:1), double-blind
N = 450
Minocycline foam 4% – 9 months of treatment
Open Label Safety Extension Subjects who complete one of the randomized, Phase 3 studies may
enter the open-label phase
• Minocycline Foam 4%
• Foam vehicle
Baseline
Acne Phase 3
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Baseline Data
• Total number of subjects: 466 (Study 04) 495 (Study 05)
• Mean age: 20.3 20.6
• Male/Female: M=42.9% F=57.1% M=41.4% F=58.6%
• Ethnicity: W=62.7% B=27.0% O=10.3% W=74.1% B=20.8% O=5.0%
Study 04 Study 05
FMX-101, 4%(N = 307)
Vehicle(N = 159)
FMX-101, 4%(N = 333)
Vehicle(N = 162)
Baseline Inflammatory Lesion Counts
Mean (SD) 32.2(8.4) 31.6(8.6) 31.6(8.6) 32.3(8.0)
Median 31 30 30 31
Range (min-max) 20-50 20-76 20-69 20-50
Baseline Non-inflammatory Lesion Counts
Mean (SD) 49.5(18.0) 46.5(16.6) 50.5(19.5) 50.9(19.9)
Baseline Total Lesion Counts
Mean (SD) 81.7(21.3) 78.1(19.7) 81.5(21.9) 83.1(23.2)
Baseline IGA Score, n (%)
3 – Moderate 255(83.1) 137(86.2) 296(88.9) 148(91.4)
4 – Severe 52(16.9) 22(13.8) 37(11.1) 14(8.6)
P<.01*P<.01*
15*ANCOVA, Intent to Treat (ITT) Population, multiple imputation
-14.16-13.46 -13.79
-11.17-10.72 -10.94
-16
-14
-12
-10
-8
-6
-4
-2
0
Study 04 Study 05 Pooled
Me
an R
ed
uct
ion
in IL
Co
un
t vs
. Bas
elin
e
Absolute Change in Inflammatory Lesion Count at Week 12
n=307 n=159 n=333 n=162FMX101 Vehicle FMX101 Vehicle
Acne Phase 3 Efficacy ResultsReduction of Inflammatory Lesion Count at Week 12
• In Study 04, absolute change in inflammatory lesion count for the FMX101, 4% treatment group was -14.16 versus -11.17 in vehicle (p=0.0071)
• In Study 05, absolute change in inflammatory lesion count for the FMX101, 4% treatment group was -13.46 versus -10.72 in vehicle (p=0.0058)
• In the Pooled Analysis, absolute change in inflammatory lesion count for the FMX101, 4% treatment group was -13.79 versus -10.94 in vehicle (p=0.0001)
FMX101 Vehicle
P<.01*
n=640 n=321
P<.05*
P<.05*
P>0.21*
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8.09%
14.67%
11.51%
4.77%
7.89%
6.34%
0%
5%
10%
15%
20%
Study 04 Study 05 Pooled
% o
f Su
bje
cts
Ach
ievi
ng
Tre
atm
en
t Su
cce
ss
IGA Treatment Success at Week 12
n=307 n=159 n=333 n=162FMX101 Vehicle FMX101 Vehicle
Acne Phase 3 Efficacy ResultsIGA Treatment Success at Week 12 [Score Clear (0) or Almost Clear (1)]
• In Study 04, IGA Treatment Success for FMX101, 4% treatment group was 8.09% versus 4.77% in vehicle (p=0.2178)
• In Study 05, IGA Treatment Success for FMX101, 4% treatment group was 14.67% versus 7.89% in vehicle (p=0.0423)
• In the Pooled Analysis, IGA Treatment Success for FMX101, 4% treatment group was 11.51% versus 6.34% in vehicle (p=0.0188)
n=640 n=321
FMX101 Vehicle
*Cochran–Mantel–Haenszel test stratified by investigational site, Intent to Treat (ITT) population, multiple imputation
P<.05*
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-16.45
-13.20
-14.76
-10.30
-7.00
-8.64
-20.00
-18.00
-16.00
-14.00
-12.00
-10.00
-8.00
-6.00
-4.00
-2.00
0.00
Study 04 Study 05 Pooled
Me
an R
ed
uct
ion
in N
IL C
ou
nt
vs. B
ase
line
Absolute Change in Non-Inflammatory Lesion Count at Week 12
n=307 n=159 n=333 n=162FMX101 Vehicle FMX101 Vehicle
Acne Phase 3 Secondary Efficacy EndpointReduction of Non-Inflammatory Lesion Count at Week 12
• In Study 04, absolute change in non-inflammatory lesion count for the FMX101, 4% treatment group was -16.45 versus -10.30 in vehicle (p=0.0042)
• In Study 05, absolute change in non-inflammatory lesion count for the FMX101, 4% treatment group was -13.20 versus -7.00 in vehicle (p=0.0320)
• In the Pooled Analysis, absolute change in inflammatory lesion count for the FMX101, 4% treatment group was -14.76 versus -8.64 in vehicle (p=0.0011)
FMX101 Vehicle
P<.01*
n=640 n=321
*ANCOVA, Intent to Treat (ITT) Population, multiple imputation
P<.01*
Acne Phase 3 Secondary Efficacy Endpoint% Change in Inflammatory Lesion Count at Weeks 3, 6, 9 and 12^
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-60%
-40%
-20%
0%
0 3 6 9 12
FMX101 (n=307)
Vehicle (n=159)
Weeks
% R
ed
uct
ion
of
IL
-60%
-40%
-20%
0%
0 3 6 9 12
FMX101 (n=333)
Vehicle (n=162)
Weeks%
Re
du
ctio
n o
f IL
^ANCOVA, Intent to Treat (ITT) Population, multiple imputation
• In Study 04, percent change in inflammatory lesion count for the FMX101, 4% treatment group at week 12 was -44% versus -34% in vehicle (p=0.0033)
• In Study 05, percent change in inflammatory lesion count for the FMX101, 4% treatment group at week 12 was -43% versus -34% in vehicle (p=0.0097)
• Statistical significance demonstrated at all timepoints (beginning at Week 3) for both Study 04 & 05
−44%
−34%
‡P≤.01; †P ≤.001; *P ≤.0001
*†
‡
†
−43%
−34%
‡
*
†
Study 04 - IL Count % Change Study 05 - IL Count % Change
*
37%
32%
20%
9% 2%
FMX101 Phase 3 Patient Satisfaction Questionnaire at Week 12, ITT Population (Observed-Cases, n=534)
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32%
42%
17%
7%2%
Overall, how satisfied are you with this
product?
Study 04 & Study 05 Pooled Analysis
How satisfied are you with this product
compared to other products you have previously used for
acne, such as gels and creams?
Scale 1- Very Satisfied2- Satisfied3- Somewhat Satisfied4- Dissatisfied5- Very Dissatisfied
~75% of subjects satisfied or very
satisfied with FMX101
~70% of subjects were satisfied or very satisfied
with FMX101 vs. other topical acne therapies
54%
31%
12%2% 1%
FMX101 Phase 3 Patient Satisfaction (cont.)
Questionnaire at Week 12, ITT Population (Observed-Cases, n=534)
20
23%
34%
27%
13%
3%
Study 04 & Study 05 Pooled Analysis
How satisfied are you with how easy this product is to use?
How satisfied are you with how this product feels on your skin after
treatment?
Scale 1- Very Satisfied2- Satisfied3- Somewhat Satisfied4- Dissatisfied5- Very Dissatisfied
>80% of patients were satisfied or very satisfied with the ease of use
of FMX101
Only 16% of patients were dissatisfied or very
dissatisfied with the product feel of FMX101
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FMX101 – Generally Safe and Well ToleratedStudy 04 AE Frequency (%)
Adverse Event FMX101, 4% Vehicle
One or more 16.9 18.2
Nasopharyngitis 2.0 3.8
Headache 2.3 3.1
CK increase 1.0 0.6
Ligament sprain 0.3 1.3
Nausea 0.7 0.6
Study 05 AE Frequency (%)
Adverse Event FMX101, 4% Vehicle
One or more 33.0 26.5
Nasopharyngitis 7.2 3.7
Headache 6.0 5.6
Upper Respiratory Tract Infection
1.8 1.2
Ligament Sprain 1.8 0.6
CK increased 1.5 2.5
Nausea 1.2 0.6
Vomiting 1.2 0.6
* Non-dermal AEs occurring in at least 1% of subjects in either group
Acne Phase 3 Safety ResultsOverall AE Frequency*
• No drug-related serious adverse events were reported • The most common systemic AE was nasopharyngitis in both studies; overall 2.6% in Study 04 and 6.1% in Study 05• Dermal adverse events were few; most were mild and included instances of acne, dermatitis, rash and discoloration.• A total of 4 subjects discontinued the Trial due to an adverse event including 2 in the active group (pruritus, worsening
acne) and 2 in the vehicle group (ectopic pregnancy, elevated liver enzymes).
FMX101 Phase 3 Results Summary
• Totality of efficacy results for FMX101 in Ph3 are positive, with inconsistent results found in only one endpoint (IGA 0/1 Treatment Success in Study 04)
• Pooled analysis of IGA 0/1 Treatment Success is statistically significant
• % Change in inflammatory lesion count is statistically significant in Study 04 and Study 05 at all timepoints (beginning at Week 3)
• Non-inflammatory lesion count reduction at Week 12 is statistically significant in Study 04 and Study 05
• Overall high level of patient satisfaction with FMX101
• FMX101 appears to be generally safe and well tolerated
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FMX101 3rd Phase 3 Study DesignStudy FX2017-22
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12-week, randomized, double-blind, vehicle controlled, in subjects with moderate-to-severe acne
Week 12(End of treatment)
Week 3
Week 6 Week 9
Double-blinded Study (-22)Randomized (1:1), double-blind
N=1,500
Commence Study Mid-2017; Topline results expected Mid-2018
◦ Minocycline Foam 4%
◦ Foam vehicle
Week 3
• 1 US Study, 1,500 subjects, ~80 sites, >9 years of age• Self-apply, once daily, for 12 weeks
• Inclusion Criteria• At least 20 inflammatory and 25 non-inflammatory lesions• IGA 5 point scale – Moderate to Severe (Grade 3 or 4)
• Co-primary Efficacy Endpoints:1. Mean change from baseline in inflammatory lesion count2. Proportion of subjects with IGA scores of “Clear” or “Almost Clear”, with improvement of at least 2 grades from
baseline
• Safety Evaluations: AEs, physical exams, vitals, dermal tolerability, erythema assessments, labs
FMX103Topical Minocycline Foam For Moderate-to-Severe Rosacea
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Rosacea
• Chronic acneiform disorder affecting both the skin and the eye
• Affects ~ 16 million adults in the US1
• Typical age of onset for rosacea – 30-60
• More common in Caucasian population
• 2 primary subtypes1
◦ Erythemato-telangiectatic – facial flushing and redness
◦ Papulopustular – acne-like papules and pustules (inflammatory lesions)
• Impact on Quality of Life2
• “Devastating impact on emotional well being”
• Low self esteem
• Affects professional interactions
251. (1) National Rosacea Society. Rosacea Review; Winter 2010. http://www.rosacea.org/rr/2010/winter/article_1.php. Accessed
May 16, 2016; (2) Wilkin J, et al. J Am Acad Dermatol. 2002;46:584-587. 2. Pathogenesis and Treatment of Acne and Rosacea, Zouboulis et al., Eds, 2014, p 743-747
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Market Leaders Volume: ~3mm TRx(~2/3rds of Total Market - $$ & TRx)
Top Brands $ USD TRxs
1 METROGEL/METRONIDAZOLE All forms, Galderma & Generics
$255,414,358 1,350,300
2 ORACEA2
Doxycyline, Galderma$219,689,492 338,160
3 FINACEA2
Azelaic Acid, Bayer$148,738,638 520,061
4 SOOLANTRAIvermectin, Galderma
$102,465,519 334,932
5 MINOCYCLINE (oral)Valeant & Generics
$43,585,959 439,525
6 MIRVASO2
Brimonidine, Galderma$40,517,131 99,378
Total Market Potential: ~$1.1 billion(Approximately 16 million people)
ORACEA2
7%
METRONIDAZOLE (all forms)
28%
FINACEA2
10%
SOOLANTRA7%
MINOCYCLINE (oral)9%
MIRVASO2
2%
OTHER37%
Top Brand Market Share, US TRxLTM December 31, 2016
77%
23%
US TRx: Topicals vs. OralsLTM December 31, 2016
Topicals
Orals
Rosacea – the US Market (2016)Undifferentiated Market with Limited Competition
Current Market (United States)1
US Dollars TRxs
Oral antibiotics $270 million 1.1 mm
Topical drugs $830 million 3.6 mm
Total $1.1 billion 4.7 mm
1. Symphony Health Services PHAST: 2016 Market Data (accessed 1.24.17), weighted values, rosacea usage2. Select brands, unweighted values (>75% rosacea usage)
Phase 2 Clinical Trial
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12-week, randomized, double-blind, dose range-finding study in subjects with moderate-to-severe papulopustular rosacea
Week 12(End of treatment)
Week 16Week: 6 10
Randomized (1:1:1), double-blindN=233
• Inclusion criteria◦ At least 12 papules and/or pustules
◦ Investigator’s Global Assessment (IGA): Moderate-to-Severe
• Efficacy endpoints◦ Absolute change in inflammatory lesion count at Week 12 compared to Baseline ◦ Investigator’s Global Assessment – IGA
◦ Proportion of subjects with IGA improvement of ≥2 grades
◦ Proportion of subjects with IGA scores of “Clear” / “Almost Clear”
• Safety & tolerability
• Minocycline foam 1.5%• Minocycline foam 3%• Foam Vehicle
1 2 4 80
Follow Up
Once daily, in the evening, for 12 weeks
28ANCOVA; multiple imputation method‡P<.05; †P<.01; *P<.001
IGA Scale: 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=SevereITT Population; Cochran–Mantel–Haenszel test; multiple imputation method
FMX103 – Phase 2 Efficacy ResultsClinically and statistically significant lesion reduction and IGA score
% Reduction of Papules & PustulesIGA = “Clear” or “Almost Clear” (Score of 0-1)
and Improvement ≥2 Grades
% S
ub
ject
s w
ith
IGA
= 0
-1
XC
P=.001
XC
P<.05
0%
5%
10%
15%
20%
25%
30%
35%
40%
FMX103 1.5% FMX103 3% Vehicle
25.3%
17.3%
7.7%
-70%
-60%
-50%
-40%
-30%
-20%
-10%
0%
0 2 4 6 8 10 12
FMX103 1.5% (n=79)
FMX103 3% (n=75)
Vehicle (n=78)
−61.4%
−55.5%
−29.7%
*
*
†
Weeks
*
*
% R
ed
uct
ion
of
Pap
ule
s &
Pu
stu
les
*
*
• No statistically significant difference between 1.5% and 3% doses
• Based on these results, FMX103 1.5% has been selected for further development
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Rosacea Phase 2 ResultsVisible Effects on Moderate-to-Severe Rosacea Subjects
Baseline Visit Week-12 Visit
30
Rosacea Phase 2 ResultsVisible Effects on Moderate-to-Severe Rosacea Subjects
Baseline Visit Week-12 Visit
Rosacea Phase 2 Results
31
Safety and Tolerability
FMX103 – Generally Safe and Well Tolerated
• No SAEs or drug-related systemic adverse events were reported
• Drug-related skin reactions (AEs):
• A total of 4 subjects discontinued the study due to an adverse event (3 in the 3% group and 1 in the vehicle group)
No. Subjects FMX103 1.5% FMX103 3% Vehicle
Eczema of face 0 1 1
Skin exfoliation/scaling 0 1 0
Erythema 0 0 1
Pruritus 0 0 1
Scab/Crust in treatment area 0 0 1
Skin burning 0 0 1
Worsening of Rosacea 0 2 0
FMX103 Phase 3 Study Design Studies FX2016-11, FX2016-12 & FX2016-13
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12-week, randomized, double-blind, vehicle controlled, in subjects with moderate-to-severe papulopustular rosacea; followed by 9 month open label safety extension
Week 12 (End of treatment) 12 MonthsWeek 2 Week 4 Week 8
Double-blinded Study (-11,-12)Randomized (2:1), double-blind
N=750 (X2)
• Minocycline Foam 1.5%
• Foam vehicleMinocycline foam 1.5% – 9 months of treatment
Open Label Safety Extension Study (-13) Subjects who complete one of the randomized, Phase 3 studies may
enter the open-label study
• 2 US Studies, ~80 sites, 750 subjects per study (N=1,500 subjects), >18 years of age• Self-apply, once daily, for 12 weeks
• Inclusion Criteria• 15 to 75 inflammatory lesions • IGA 5 point scale – Moderate to Severe (Grade 3 or 4)
• Co-primary Efficacy Endpoints:1. Mean change from baseline in inflammatory lesion count2. Proportion of subjects with IGA scores of “Clear” or “Almost Clear”, with improvement of at least 2 grades
from baseline
• Safety Evaluations: AEs, physical exams, vitals, dermal tolerability, erythema assessments, labs
Commence Study Mid-2017; Topline results expected Mid-2018
Upcoming Milestones
33
TLR (Studies 04 & 05)
Mar 27
3rd Ph3 DB (Study 22)
Ph3 LTS
3rd Ph3 TLR
NDA
PDUFA
Ph3 DB (Studies 11 & 12)
Ph3 TLR (DB)
Ph3 LTS
NDA
PDUFA
2017 2020H12017
H2H12018
H2H12019
H2H12020
H2
FMX101, 4% (Acne)
FMX103, 1.5% (Rosacea)
TLR = Topline Results*Actual timelines may vary
Commercial Landscape
34
Recent Acne/Rosacea Product Launches
35
Significant Rx Adoption and Revenue Within 1 year of Commercialization
Source: Symphony Health Analytics PHAST (accessed 1.24.17).
Months since launch
TRx
per
mo
nth
-
10,000
20,000
30,000
40,000
50,000
1 2 3 4 5 6 7 8 9 10 11 12
Acticlate -2014(Doxycycline Tablets)
Aczone 7.5% -2016(Dapsone Gel Pump)
Epiduo Forte -2015(Adapalene/BPO Gel Pump)
Onexton -2015(Clindamycin/BPO Gel Pump)
Soolantra -2015 (Ivermectin Cream) Finacea Foam -2015(Azelaic Acid)
Valeant – PhilidorControversy
A Pro-Commercial Reimbursement Environment Payer mix: branded acne drugs (all payer types / 2016)
Source: Symphony Health Analytics PHAST (accessed 1.24.17).(1) Assistance Programs include aid for “medically indigent” patients (those who are without insurance, have low income or are ineligible for public programs) which can be privately or State funded and coupon programs that have been identified and profiled.
Commercial Payers and Cash account for ~80% of total reimbursement within the Oral Branded Market.
Oral
Commercial Payers and Cash account for ~80% of total reimbursement within the Topical Branded Market.
Topical
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ASSISTANCE PROGRAMS, 11%
CASH , 3%
COMMERCIAL, 77%
MANAGED MEDICAID , 4%
MEDICAID , 4%
MEDICARE , 1%
Other, 23%
ASSISTANCE PROGRAMS,
20%
CASH , 2%COMMERCIAL,
77% MANAGED MEDICAID , 0%
MEDICAID , 0%
MEDICARE , 1%
Other, 3%
(1)
(1)
Rx Volume Driven by Small Prescriber Base
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Total Active Derms(~15,000)
Rx Volume (80%)
Rx Volume(100%)
• ~1/3 of Dermatologists generate ~80% of Rx volume
• Optimal Sales Force size < 100 representatives
Target Universe
Derms(~5000)
Ability to reach prescriber base with a lean salesforce and maximize commercial efforts
Source: Symphony Health Analytics DCL (Dynamic Claims Lifecycle). Data from 2015-2016.
Collaborations
• Development and licensing agreements with pharmaceutical companies
• Each license agreement is product specific (Licensee’s drug)
• Licensed products are currently in preclinical, Phase 2, Phase 3 and commercial stages
• Foamix owns the IP for the drug delivery platform
• Foamix retains the rights to develop products for the same indications using our foam technology in conjunction with other drugs
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• Upfront payments, contingent payments and royalties on sales of products that are commercialized
• Total of ~$25.4 million cumulative revenues as of March 31, 2017
• Recurring royalties since Q4, 2015
Revenues
Nasdaq: FOMX
May 2017